U.S. patent application number 17/747292 was filed with the patent office on 2022-09-01 for prosthetic heart valve cooling.
This patent application is currently assigned to Medtronic Vascular, Inc.. The applicant listed for this patent is Medtronic Vascular, Inc.. Invention is credited to Joshua Dudney, Laura McKinley, Karl Olney, Tracey Tien, Wei Wang, Benjamin Wong.
Application Number | 20220273425 17/747292 |
Document ID | / |
Family ID | 1000006336947 |
Filed Date | 2022-09-01 |
United States Patent
Application |
20220273425 |
Kind Code |
A1 |
Wang; Wei ; et al. |
September 1, 2022 |
PROSTHETIC HEART VALVE COOLING
Abstract
Devices for, and methods of, compressing a stented prosthetic
heart valve are disclosed. The method including inserting a stented
prosthetic heart valve having a self-expandable stent frame into a
container, initiating a cooling element in the container,
transferring heat through a thermal conductor to cool an interior
of the container, reducing a temperature of the self-expandable
stent frame while located within the container to a critical
temperature of not greater than 8.degree. C., and compressing an
outer diameter of the stented prosthetic heart valve while the
stented prosthetic heart valve is at the critical temperature.
Inventors: |
Wang; Wei; (Santa Rosa,
CA) ; Wong; Benjamin; (Santa Rosa, CA) ;
McKinley; Laura; (Santa Rosa, CA) ; Dudney;
Joshua; (Santa Rosa, CA) ; Tien; Tracey;
(Santa Rosa, CA) ; Olney; Karl; (Santa Rosa,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Assignee: |
Medtronic Vascular, Inc.
Santa Rosa
CA
|
Family ID: |
1000006336947 |
Appl. No.: |
17/747292 |
Filed: |
May 18, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16854095 |
Apr 21, 2020 |
11364115 |
|
|
17747292 |
|
|
|
|
16123047 |
Sep 6, 2018 |
10660746 |
|
|
16854095 |
|
|
|
|
14990657 |
Jan 7, 2016 |
10092398 |
|
|
16123047 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/9522 20200501;
B65B 63/02 20130101; A61F 2/2427 20130101; B65B 63/08 20130101;
A61F 2/9525 20200501; A61F 2/2409 20130101; A61F 2/2418
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61F 2/95 20060101 A61F002/95; B65B 63/02 20060101
B65B063/02; B65B 63/08 20060101 B65B063/08 |
Claims
1. A device for compressing a stented prosthetic heart valve, the
device comprising: an inner wall defining a dwell chamber sized and
shaped for receiving an entirety of a stented prosthetic heart
valve in an expanded state, the cooling chamber defining a leading
side opposite a trailing side; an outer wall connected to and
surrounding an exterior of the inner wall to define a cooling
chamber between the inner and outer walls; a cooling element
maintained within the cooling chamber; and a cap extending from the
leading side and defining a passageway open to the dwell chamber
and closed to the cooling chamber, wherein a diameter of the
passageway tapers in extension from the dwell chamber.
2. The device of claim 1, wherein the passageway terminates at a
delivery port opposite the dwell chamber, and further wherein a
diameter of the passageway at the delivery port is less than a
diameter of the dwell chamber.
3. The device of claim 2, wherein the passageway is configured to
compress a stented prosthetic heart valve as the prosthetic heart
valve is extracted from the dwell chamber, along the passageway,
and through the delivery port.
4. The device of claim 1, further comprising a bottom wall
extending across the trailing side of the inner wall, the bottom
wall closing the dwell chamber at the trailing side.
5. The device of claim 4, wherein the bottom wall extends across
the outer wall to close the cooling chamber.
6. The device of claim 1, wherein the cap is removably assembled to
the inner wall.
7. The device of claim 6, wherein the cap is removably assembled to
the outer wall.
8. The device of claim 7, wherein in the device is configured such
that the cap closes the cooling chamber when assembled to the outer
wall, and when the cap is disassembled from the outer wall, the
cooling chamber is open.
9. The device of claim 1, wherein the cooling element includes
first and second liquids that, when combined, generate an
endothermic reaction.
10. The device of claim 1, wherein the cooling element includes a
coil containing a refrigerant.
11. The device of claim 1, wherein the cooling element includes a
thermoelectric cooler.
12. A combination stented prosthetic heart valve and compressing
device, the combination comprising: a stented prosthetic heart
valve; and a compressing device comprising: an inner wall defining
a dwell chamber sized and shaped for receiving an entirety of the
stented prosthetic heart valve in an expanded state, the cooling
chamber defining a leading side opposite a trailing side, an outer
wall connected to and surrounding an exterior of the inner wall to
define a cooling chamber between the inner and outer walls, a
cooling element maintained within the cooling chamber, a cap
extending from the leading side and defining a passageway open to
the dwell chamber and closed to the cooling chamber, wherein a
diameter of the passageway tapers in extension from the dwell
chamber.
13. The combination of claim 12, wherein the combination is
configured to provide a cooling state in which the stented
prosthetic heart valve is maintained in the dwell chamber and the
cooling element is operated to transfer heat from the dwell chamber
to reduce a temperature of the stented prosthetic heart valve below
a critical temperature.
14. The combination of claim 13, wherein the combination is further
configured to provide a compressing state in which the stented
prosthetic heart valve, maintained below the critical temperature,
is extracted from the dwell chamber through the passageway to
compress the stented prosthetic heart valve.
15. The combination of claim 12, wherein the cooling device further
comprising a bottom wall extending across the trailing side of the
inner wall, the bottom wall closing the dwell chamber at the
trailing side.
16. The combination of claim 15, wherein the bottom wall extends
across the outer wall to close the cooling chamber.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 16/854,095, filed Apr. 21, 2020, which is a
Continuation of U.S. patent application Ser. No. 16/123,047, filed
Sep. 6, 2018, now U.S. Pat. No. 10,660,746, entitled "PROSTHETIC
HEART VALVE COOLING", which is a Continuation of U.S. patent
application Ser. No. 14/990,657, filed Jan. 7, 2016, now U.S. Pat.
No. 10,092,398, entitled "PROSTHETIC HEART VALVE COOLING" the
contents of each of which are incorporated herein by reference.
BACKGROUND
[0002] The present disclosure relates to implantable prosthetic
heart valves. More particularly, it relates to prosthetic heart
valves incorporating a stent and methods of compressing stented
prosthetic heart valves for loading into a delivery system.
[0003] Various types and configurations of prosthetic heart valves
are used to replace diseased natural human heart valves. The actual
shape and configuration of any particularly prosthetic heart valve
is dependent to some extent upon the valve being replaced (i.e.,
mitral valve, tricuspid valve, aortic valve, or pulmonary valve).
In general, the prosthetic heart valve designs attempt to replicate
the function of the valve being replaced and thus will include
valve leaflet-like structures used with either bioprosthesis or
mechanical heart valves prosthesis. As used throughout the
specification, a "prosthetic heart valve" is intended to encompass
bioprosthetic heart valves having leaflets made of a biological
material (e.g., harvested porcine valve leaflets, or bovine,
equine, ovine or porcine pericardial leaflets, small intestinal
submucosa), along with synthetic leaflet materials or other
materials.
[0004] Stented bioprosthetic heart valves have a frame (or stent)
to which the biological valve material is attached. The biological
valve members are sutured to the stent that provides support for
the valve member in the patient's body. The stent prevents the
biological valve members from collapsing and simplifies the
insertion of the valve into the annulus of the patient after
excision of the diseased valve. The stented bioprosthetic valve
imitates the natural action of heart valves and provides a
structure that is relatively compatible with the cardiovascular
system. Stented prosthetic heart valves are believed to have
important clinical advantages over mechanical or non-tissue
prosthetic valves.
[0005] For many percutaneous delivery and implantation systems, the
stent frame of the valved stent is made of a self-expanding
material and construction. The stent frame is made of nitinol (a
nickel and titanium alloy). With these systems, the valved stent is
crimped down to a desired size and held in that compressed
arrangement within an outer sheath, for example. Retracting the
sheath from the valved stent allows the stent to self-expand to a
larger diameter, such as when the valved stent is in a desired
position within a patient.
[0006] Typically a stented transcatheter valve having a
self-expanding frame, such as a nitinol based frame, is cooled
prior to loading into the delivery system. The cooling process
brings the valve out of the austenitic and into the martensitic
phase. While in the martensitic phase, nitinol is more malleable.
Often an ice bath based solution of approximately 4.degree. C. is
employed in order that the nitinol frame enters the martensitic
state and becomes malleable and can be compressed for loading to a
delivery system. In some stented transcatheter valves, the tissue
used in the valve is in a "dry" state and is processed using
glycerine, alcohols, other chemicals, and combinations thereof
rather than a "wet" state and processed with excess glutaraldehyde.
In valves including "dry" tissue, it is desirable to maintain the
tissue in a dry state and avoid processes that use aqueous or
liquid solutions. For dry tissue loaded onto a nitinol based frame
or other self-expanding frame, it is desirable to cool the frame to
a malleable, collapsible, state without exposing the tissue to an
aqueous solution.
SUMMARY
[0007] One aspect of the present disclosure includes a method of
compressing a stented prosthetic heart valve. The method including
inserting a stented prosthetic heart valve having a self-expandable
stent frame into a container. A cooling element is initiated in the
container. Heat is transferred through a thermal conductor to cool
an interior of the container. A temperature of the self-expandable
stent frame is reduced while located within the container to a
critical temperature. An outer diameter of the stented prosthetic
heart valve is compressed while the stented prosthetic heart valve
is at the critical temperature.
[0008] Another aspect of the present disclosure includes a method
of loading a stented prosthetic heart valve to a transcatheter
delivery system. The method includes inserting a stented prosthetic
heart valve in an expanded state into a first chamber of a cooling
vessel. Cooling is initiated in a second chamber of the cooling
vessel. Heat is transferred from the first chamber to the second
chamber through a thermally conductive wall to cool an interior of
the first chamber. A temperature of the stented prosthetic heart
valve is reduced to the critical temperature while located within
the first chamber. The stented prosthetic heart valve is removed
from the first chamber. The stented prosthetic heart valve is
compressed while at the critical temperature. The compressed
stented prosthetic heart valve is inserted into a delivery
system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1A is a perspective view of a cooling vessel in
accordance with principles of the present disclosure;
[0010] FIG. 1B is a perspective cross-sectional view of the cooling
vessel of FIG. 1A in accordance with principles of the present
disclosure;
[0011] FIGS. 2A-2C are a schematic perspective views of exemplary
cooling devices in accordance with principles of the present
disclosure; and
[0012] FIGS. 3A-3B are flow charts of methods of using a cooling
device in accordance with principles of the present disclosure.
DETAILED DESCRIPTION
[0013] The methods and devices of the present disclosure are useful
in cooling a stented prosthetic heart valve having a
self-expandable stent frame without exposing the stented prosthetic
heart valve to liquid during cooling. The stented prosthetic heart
valve or other device can be in a wet state or a dry state. The
stented prosthetic heart valve or other device can desirably be
processed and maintained in a dry state in accordance with aspects
of the present disclosure. Regardless, in accordance with aspects
of the present disclosure, the stented prosthetic heart valve is
fluidly separated from the cooling element while positioned within
the cooling device, and is thus, indirectly exposed to the cooling
element. In other words, the stented prosthetic heart valve is not
directly exposed to the cooling element during cooling. In
accordance with the present disclosure, heat is removed from the
stented prosthetic heart valve disposed in the cooling vessel via
the cooling element disposed within the cooling vessel in isolation
from the stented prosthetic heart valve.
[0014] FIGS. 1A and 1B illustrate perspective and cross-sectional
views of a cooling device 10 useful in cooling a medical device
such as a stented prosthetic heart valve in accordance with aspects
of the present disclosure. The cooling device 10 is suitable to
accommodate housing a cooling element and a stented prosthetic
heart valve (not shown) separately. The cooling device 10 includes
a cooling vessel 11 having a first chamber 12 suitable for
containing the stented prosthetic heart valve separate from the
second chamber 14 suitable for accommodating the cooling element.
The first chamber 12 is sized and shaped to accommodate a single
valve in both expanded and compressed states. A first, or inner,
sidewall 16 defines a perimeter of the first chamber 12. The first
sidewall 16 can be formed of a rigid, thermally conductive material
such as stainless steel or ceramic, for example. The second chamber
14 is defined between the first sidewall 16 and a second, exterior,
sidewall 18. In some embodiments, the cooling device 10 is
cylindrical and the second chamber 14 has a larger diameter than
the first chamber 12. In other words, in some examples, the second
chamber 14 encircles the first chamber 12. The first sidewall 16
separates the first chamber 12 from the second chamber 14.
[0015] A bottom cap 20 extends across both the first and second
chambers 12, 14 along lower wall edges of the first and second
sidewalls 16, 18 to seal the chambers 12, 14 at a first end 22. The
bottom cap 20 can be planar, stepped, or other surface shapes. The
bottom cap 20 is suitable to provide a resting surface for
placement of the cooling vessel 11 on a table or countertop, for
example. The first and second chambers 12, 14 are fluidly separated
from one another along the first sidewall 16 and the bottom cap 20.
A second end 24, opposite the first end 22, provides access to the
first and second chambers 12, 14.
[0016] In one embodiment, the first chamber 12 has a diameter that
is at least slightly greater than the size of a single stented
prosthetic heart valve (not shown) in a fully expanded state. The
first chamber 12 is sized such that an air gap, or space, can be
formed between the expanded heart valve and the first sidewall 16
when the heart valve is housed in the first chamber 16. The air gap
can allow for a generally even conductance of cooling through the
first sidewall 16, from the cooling element housed in the second
chamber 14, to the valve in the first chamber 12. The second
chamber 14 is sized to accommodate a cooling element and surround
at least a side perimeter of the first chamber 12.
[0017] The cooling device 10 can include a top cap 26 operably
removable from the cooling vessel 11. The top cap 26 can be coupled
to the second end 24 of the cooling vessel 11. The top cap 26 is
removable, or operable, to provide access to at least the first
chamber 12. In some embodiments, the top cap 26 can provide access
to both the first and second chambers 12, 14. The top cap 26 can
include a funneling portion 28 extending above and away from the
first chamber 12. In one embodiment, the funneling portion 28 is
centrally positioned on the top cap 26. The funneling portion 28 is
centrally aligned with the first chamber 12 when the top cap 26 is
coupled to the cooling vessel 11. An interior 29 of the funneling
portion 28 is fluidly open to the first chamber 12. The funneling
portion 28 can be a truncated conical shape, for example, with a
base 30 and a delivery port 32 opposite the base 30. The funneling
portion 28 tapers inwardly from the base 30 to the delivery port
32. The base 30 has a diameter that is greater than a diameter of
the delivery port 32. A diameter of the base 30 of the funneling
portion 28 is approximately equal to the diameter of the first
chamber 12. In one embodiment, the diameter of the base 30 of the
funneling portion 28 is slightly smaller than the diameter of first
sidewall 16. A rim 34 radially extends outward from the base of the
funneling portion 28. A lower surface 36 of the rim 34 provides a
coupling surface with the second end 24 of the cooling vessel 11.
The funneling portion 28 can provide compression of the stented
prosthetic heart valve during extraction of the cooled malleable
valve from the first channel 12, passing through the funneling
portion 28 and exiting through the delivery port 32 of the cooling
device 10.
[0018] In some embodiments, the top cap 26 can be mated and aligned
to the cooling vessel 11 when coupled. For example, the top cap 26
can include alignment slots 38 that can be matingly engaged with
alignment tabs 40 of the cooling vessel 11. In some embodiments,
the top cap 26 releasably, lockingly engages with the cooling
vessel 11. A collar 42 can be included at the delivery port 32 of
the funneling portion 28. The collar 42 is a circular segment of a
diameter smaller than the base 30 diameter. In some embodiment, a
lid or plug (not shown) may be included at the delivery port 32 to
temporarily seal the interior of the funneling portion 28 and the
first chamber 12 from ambient air and retain the cooled air in the
first chamber 12 when the cooling element is initiated. A height of
the top cap 26 can be substantially equivalent to a height of the
cooling vessel 11, with both the top cap 26 and the cooling vessel
11 being at least slightly greater than a height of the stented
prosthetic heart valve. The top cap 26 minimizes heat entering the
first chamber 12 from the ambient air and cooling escaping from the
first and second chambers 12, 14 into the ambient air during
cooling.
[0019] With further reference to the cross-section of the cooling
device 10 illustrated in FIG. 1B, an interior surface of the first
sidewall 16 and bottom cap 20 within the first chamber 12 can
include projections 44. The projections 44 are formed of a
non-conductive material such as polymer, for example, or other
non-conductive material. The projections 44 can assist in
maintaining a valve a desired distance from the thermally
conductive first sidewall 16. The projections 44 can assist in
maintaining a valve centered within the first chamber 12. In FIG.
1B, a single ring-shaped projection 44 is illustrated as an
example. The projections 44 can be ring-shaped, rounded bumps, or
any other suitable shape.
[0020] The cooling device 10 is portable and can be handheld. The
cooling device 10 is easily transportable into a surgical theater,
for example, and is sterilizable. In one embodiment, the stented
prosthetic heart valve is loaded into the cooling device 10,
cooled, and compressed for loading onto a delivery system during
the manufacturing process. In one embodiment, the stented
prosthetic heart valve is inserted into the first chamber 12 of the
cooling device 10 for cooling. One of the cooling systems described
below is initiated causing the self-expandable frame of the stented
prosthetic heart valve to cool to a critical malleable temperature.
The critical temperature can vary based on the valve design and
heat treatment process; however, a typical value can be 4-8.degree.
C. In one embodiment, the critical temperature is less than or
equal to 10.degree. C. (Celsius). The stented prosthetic heart
valve remains fluidly separated from the cooling element during the
entirety of cooling. The cooling devices in accordance with the
present disclosure can be employed to remove heat from the first
chamber 12 and the stented prosthetic heart valve removably
contained within the first chamber 12. The first sidewall 16 is a
thermal conductor. Heat is transferred from the first chamber 12
through the thermally conductive first sidewall 16 to cool the
first chamber via the cooling element in the second chamber 14. The
self-expandable stent frame of the stented prosthetic heart valve
can be comprised of nitinol, for example. Nitinol is malleable at
cool temperatures. The temperature of the self-expanding stent
frame can be reduced to the critical temperature and the outer
diameter of the stented prosthetic heart valve can be compressed
while at the critical temperature. The stented prosthetic heart
valve is extracted through the delivery port 32, and can be
compressed during extraction through the funneling portion 28, for
loading onto the delivery system. The stented prosthetic heart
valve can then be packaged on the delivery system for use in the
surgical theater. The stented prosthetic heart valve is fluidly
separated from and indirectly exposed to the cooling element as
described further below.
[0021] FIG. 2A is a cross-sectional illustration of a cooling
device 110 including a cooling element 150 in accordance with
principles of the present disclosure. Similar to the cooling device
10 of FIG. 1A-1B and described above, the cooling device 110
includes the first chamber 12 suitable for removably containing the
stented prosthetic heart valve and the second chamber 14 suitable
for accommodating the cooling element 150. The first chamber 12 is
sized and shaped to accommodate the valve in expanded and
compressed states. The first sidewall 16 defines a perimeter of the
first chamber 12 and is formed of a rigid, thermally conductive
material. The second chamber 14 is defined between the first
sidewall 16 and a second sidewall 118. In one embodiment, the
cooling element 150 housed in the second chamber 14 is divided into
two portions 14a, 14b with a thin barrier 52 fluidly separating the
two portions 14a, 14b. The barrier 52 can be positioned and extend
between the first sidewall 16 and the second sidewall 118. The
barrier 52 can be positioned in any suitable manner to fluidly
separate the two portions 14a, 14b within the second chamber 14. In
one embodiment, the second sidewall 118 is flexible and can be
manipulated with applied pressure. The barrier 52 can be pierced,
broken, or otherwise ruptured by an application of pressure. For
example, rupture or failure of the barrier 52 can be caused by
squeezing of the second sidewall 118 and the barrier 52 inward as
indicated by arrows "A" toward the first sidewall 16 until failure
of the barrier 52 occurs. In one embodiment, water contained in the
first portion 14a of the second chamber 14 is initially separated
from chemicals (e.g., ammonium nitrate) contained in a second
portion 14b. Upon failure of the barrier 52, an endothermic
reaction occurs in response to a reaction of the chemicals from the
second portion 14b contacting and mixing with water in the first
portion 14a.
[0022] FIG. 2B is a cross-sectional illustration of a cooling
device 210 including a cooling element 250 in accordance with
principles of the present disclosure. The cooling device 210
includes a first chamber 12 suitable for removably containing the
stented prosthetic heart valve and a second chamber 14 suitable for
accommodating the cooling element 250. The first chamber 12 is
sized and shaped to accommodate the valve in expanded and
compressed states. The first sidewall 16 defines a perimeter of the
first chamber 12 and is formed of a rigid, thermally conductive
material. The second chamber 14 is defined between the first
sidewall 16 and a second sidewall 218. In one embodiment, the
second sidewall 218 is a rigid wall. An inlet port 54 is included
providing at the second wall 218. The inlet port 54 can include a
luer coupling or other appropriate coupling means suitable to
connect for delivery of cooling fluid into an interior of the
second chamber 14. The interior of the second chamber 14 can
include coils 56 for circulating the coolant, or refrigerant such
as Freon, for example, within the second chamber 14. In one
embodiment, the coils 56 wrap around and contact the outer surface
of the first sidewall 16. Heat is transferred from the first
chamber 12 and the valve housed within the first chamber 12 upon
initiating cooling of the cooling element 250.
[0023] A cooling device 310 illustrated in FIG. 2C is similar to
the cooling devices 110, 210 described above. The cooling device
310 includes a first chamber 12 suitable for removably containing
the stented prosthetic heart valve and a second chamber 14 suitable
for accommodating a cooling element 350. Cooling element 350 is a
thermoelectric cooler (TEC). The first chamber 12 is sized and
shaped to accommodate the valve in expanded and compressed states.
A first sidewall 16 defines a perimeter of the first chamber 12.
The first sidewall 16 can be formed of a rigid, thermally
conductive material, for example, stainless steel or ceramic. The
second chamber 14 is defined between the first sidewall 16 and a
second sidewall 318. The second sidewall 318 is a rigid wall. A
power source is coupled to the cooling device at a connection 352
positioned at the second wall 318 to power, or apply a voltage
across, the TEC 350 to apply cooling to the first chamber 12 and
valve housed therein. The TEC transfers heat from the first chamber
12, on the interior side of the TEC, to the exterior side of the
TEC and second chamber 14 housing the TEC.
[0024] FIG. 3A is a flow chart of a method of compressing a stented
prosthetic heart valve. The method includes a step 402 of inserting
a stented prosthetic heart valve having a self-expandable stent
frame into a cooling vessel. At step 404, a cooling element is
initiated. At step 406, heat is transferred through a thermally
conductive wall to cool an interior of the container. At step 408,
the temperature of the self-expandable stent frame is reduced while
located within the container to a critical temperature of not
greater than 8.degree. C. At step 410, an outer diameter of the
stented prosthetic heart valve is compressed while the stented
prosthetic heart valve is at the critical temperature.
[0025] FIG. 3B is a flow chart of a method of loading a stented
prosthetic heart valve to a transcatheter delivery system. The
method includes a step 502 of inserting a stented prosthetic heart
valve in an expanded state into a first chamber of a cooling
vessel. The top cap 26 of the cooling device can be coupled to the
cooling vessel after inserting the stented prosthetic heart vessel,
isolating the valve from directly contacting a cooling element. At
step 504, cooling is then initiated in a second chamber of the
cooling vessel. In one embodiment, cooling is initiated by manually
compressing the exterior of the cooling vessel to cause mixing of
reagents for an endothermic reaction. In another embodiment,
cooling is initiated with thermoelectric cooling. In another
embodiment, cooling is initiated with circulating coolant in the
second chamber of the cooling vessel. The circulating coolant, or
other cooling element, is fluidly separated from the stented
prosthetic heart valve within the cooling vessel during cooling.
Regardless, of the manner of cooling, the valve is maintained in a
dry state. At step 506, heat is transferred from the first chamber
to the second chamber through a thermally conductive wall to cool
an interior of the first chamber. At step 508, a temperature of the
stented prosthetic heart valve is reduced while located within the
first chamber to a critical temperature of not greater than
8.degree. C. The step of reducing the temperature of the stented
prosthetic heart valve includes the first chamber being free of
liquid. At step 510, the stented prosthetic heart valve is removed
from the first chamber. At step 512, the stented prosthetic heart
valve is compressed while at the critical temperature. At step 514,
the compressed stented prosthetic heart valve is inserted into, or
mounted onto, a delivery system. Notably, steps 502-514 can be
completed while maintaining the stented prosthetic heart valve in a
dry state.
[0026] Although the present disclosure has been described with
reference to preferred embodiments, workers skilled in the art will
recognize that changes can be made in form and detail without
departing from the spirit and scope of the present disclosure.
* * * * *